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Commit 75ba1c4c authored by Liliana Sanfilippo's avatar Liliana Sanfilippo
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...@@ -25,7 +25,7 @@ export function HPEducation(){ ...@@ -25,7 +25,7 @@ export function HPEducation(){
<p>Human-centered design is essential for our Integrated Human Practices, ensuring that our project is aligned with the real needs and concerns of the people it aims to serve. Outreach and education are key components of this approach, as they allow us to communicate our goals and inform the public about both our project and the critical issue of cystic fibrosis (CF). By engaging with diverse audiences—patients, families, schools, and the wider community—we raise awareness about CF, while fostering a deeper understanding of the challenges involved. This feedback-driven interaction not only builds trust but also helps us refine our work to have a meaningful impact on those affected by CF. Through educational programs, workshops, and outreach initiatives, we aim to bridge the gap between scientific research and the public, ensuring that our project is both accessible and impactful.</p> <p>Human-centered design is essential for our Integrated Human Practices, ensuring that our project is aligned with the real needs and concerns of the people it aims to serve. Outreach and education are key components of this approach, as they allow us to communicate our goals and inform the public about both our project and the critical issue of cystic fibrosis (CF). By engaging with diverse audiences—patients, families, schools, and the wider community—we raise awareness about CF, while fostering a deeper understanding of the challenges involved. This feedback-driven interaction not only builds trust but also helps us refine our work to have a meaningful impact on those affected by CF. Through educational programs, workshops, and outreach initiatives, we aim to bridge the gap between scientific research and the public, ensuring that our project is both accessible and impactful.</p>
<p></p> <p></p>
</div> </div>
<div id="akademie" className="edu-cycletab" style={{display: "none"}}> <div id="akademie" className="edu-cycletab" style={{display: "none"}}>
<H4 id="student-academy-heading" text="Student academy on the topic of synthetic biology"/> <H4 id="student-academy-heading" text="Student academy on the topic of synthetic biology"/>
<H5 id="Schüler*innen Akademie" text="Teaching the Next Generation of SynBio Pioneers "/> <H5 id="Schüler*innen Akademie" text="Teaching the Next Generation of SynBio Pioneers "/>
...@@ -51,7 +51,7 @@ Due to our collaboration with the Student Academy, we conducted the nanopore seq ...@@ -51,7 +51,7 @@ Due to our collaboration with the Student Academy, we conducted the nanopore seq
<p>Our goal was to educate children about the challenges faced by CF patients, especially the ones with lung problems. The knowledge which we gained at the Science Communication Workshop as part of the BFH Meetup was the optimal basis to plan our outreach to the public. We engaged the children with activities like coloring lung images and conducting experiments to experience and understand lung related symptoms. <p>Our goal was to educate children about the challenges faced by CF patients, especially the ones with lung problems. The knowledge which we gained at the Science Communication Workshop as part of the BFH Meetup was the optimal basis to plan our outreach to the public. We engaged the children with activities like coloring lung images and conducting experiments to experience and understand lung related symptoms.
One such experiment involved creating a lung model from balloons and straws, demonstrating the difficulty patients have in breathing by having the children blow into the straws. Additionally, we set up a tank with a mixture of starch and water to simulate mucus and placed a ball on top. The children tried to blow the ball across the surface, illustrating how hard it is for air to move through mucus compared to water, where the ball moved much more easily. One such experiment involved creating a lung model from balloons and straws, demonstrating the difficulty patients have in breathing by having the children blow into the straws. Additionally, we set up a tank with a mixture of starch and water to simulate mucus and placed a ball on top. The children tried to blow the ball across the surface, illustrating how hard it is for air to move through mucus compared to water, where the ball moved much more easily.
The very little ones could paint coloring pages which we designed and printed for them. For the adults, we provided information about our project and discussed the implications and potential of gene therapy for cystic fibrosis. These conversations made it abundantly clear that degrees of knowledge on this topic widely vary throughout the public and we were happy to fill in the existing gaps in people's knowledge and exchange points of view on gene therapy. The very little ones could paint coloring pages which we designed and printed for them. For the adults, we provided information about our project and discussed the implications and potential of gene therapy for cystic fibrosis. These conversations made it abundantly clear that degrees of knowledge on this topic widely vary throughout the public and we were happy to fill in the existing gaps in people's knowledge and exchange points of view on gene therapy.
Moreover, we connected with other institutions and participants at the event. We shared our booth at Bielefeld’s “Skulpturenpark” on the outside with btS, the life science student initiative from Bielefeld University [LINK], with whose members we had stimulating discussions as well. We were more than delighted when the city of Bielefeld featured us on their Instagram, highlighting our presence during "Der Teuto ruft!". This collaboration helped us reach a wider audience and raise awareness about our research efforts.</p> Moreover, we connected with other institutions and participants at the event. We shared our booth at Bielefeld’s “Skulpturenpark” on the outside with btS, the life science student initiative from Bielefeld University <a href="https://bts-ev.de/bielefeld/"></a>, with whose members we had stimulating discussions as well. We were more than delighted when the city of Bielefeld featured us on their Instagram, highlighting our presence during "Der Teuto ruft!". This collaboration helped us reach a wider audience and raise awareness about our research efforts.</p>
<H5 id="conclusion? " text="What is our conclusion"/> <H5 id="conclusion? " text="What is our conclusion"/>
<p>Despite the changeable weather, we could educate many people of Bielefeld's community about cystic fibrosis, our therapeutic approach and gene therapy in general and had the opportunity to improve our science communication for the future as well so it was a successful event! </p> <p>Despite the changeable weather, we could educate many people of Bielefeld's community about cystic fibrosis, our therapeutic approach and gene therapy in general and had the opportunity to improve our science communication for the future as well so it was a successful event! </p>
<div className="row align-items-center"> <div className="row align-items-center">
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...@@ -39,7 +39,7 @@ export function HPOutreach(){ ...@@ -39,7 +39,7 @@ export function HPOutreach(){
<p>The sale took place in cystic fibrosis awareness month May in the Great Hall of our University. As people passed by, we engaged them by introducing our research group and explaining our project’s objectives. We shared information about cystic fibrosis and why we are raising money. Our goal was to not only just to sell waffles, but also to educate the university community about our research and its’ potential impact. The response has been overwhelmingly positive. Many were genuinely interested in our work and asked for more details about our research and the goals of our project. This enthusiasm strengthened our commitment to the project and highlighted the importance of community involvement in scientific research. </p> <p>The sale took place in cystic fibrosis awareness month May in the Great Hall of our University. As people passed by, we engaged them by introducing our research group and explaining our project’s objectives. We shared information about cystic fibrosis and why we are raising money. Our goal was to not only just to sell waffles, but also to educate the university community about our research and its’ potential impact. The response has been overwhelmingly positive. Many were genuinely interested in our work and asked for more details about our research and the goals of our project. This enthusiasm strengthened our commitment to the project and highlighted the importance of community involvement in scientific research. </p>
<p>The waffle sale was a great success, both in terms of raising funds and increasing awareness about our work within the university. It was a collaborative effort that brought our team closer together and demonstrated the power of community support in advancing scientific research. </p> <p>The waffle sale was a great success, both in terms of raising funds and increasing awareness about our work within the university. It was a collaborative effort that brought our team closer together and demonstrated the power of community support in advancing scientific research. </p>
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<img src="https://static.igem.wiki/teams/5247/photos/edcation-and-outreach/screenshot-2024-09-25-202008.png"/> <img src="https://static.igem.wiki/teams/5247/photos/edcation-and-outreach/screenshot-2024-09-25-202008.png" style={{width:"60%", height:"70%"}}/>
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<div id="mukomove" className="out-cycletab" style={{display: "none"}}> <div id="mukomove" className="out-cycletab" style={{display: "none"}}>
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...@@ -11,10 +11,10 @@ export function igemBielefeld() { ...@@ -11,10 +11,10 @@ export function igemBielefeld() {
<Section title="History" id="History"> <Section title="History" id="History">
<div className="row"> <div className="row">
<div className="col"> <div className="col">
<img src="https://static.igem.wiki/teams/5247/sponsors/uni-bielefeld-dunkel.png" style={{width:"50%", height:"30%"}}/> <img src="https://static.igem.wiki/teams/5247/sponsors/uni-bielefeld-dunkel.png" style={{width:"50%", height:"50%"}}/>
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<div className="col"> <div className="col">
<img src="https://static.igem.wiki/teams/5247/sponsors/cebitec-logo-hinterlegt.png" style={{width:"50%", height:"30%"}}/> <img src="https://static.igem.wiki/teams/5247/sponsors/cebitec-logo-hinterlegt.png" style={{width:"50%", height:"50%"}}/>
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...@@ -134,7 +134,7 @@ export const Safety: React.FC = () =>{ ...@@ -134,7 +134,7 @@ export const Safety: React.FC = () =>{
</div> </div>
</Section> </Section>
<Section title="Biosafety" id="Biosafety"> <Section title="Biosafety" id="Biosafety">
<Subesction title="Mechanism" id="Biosafety1"> <Subesction title="Safety aspects of our PrimeGuide" id="Biosafety1">
<p> <p>
The biosafety of our Prime Editing complex has been a top priority throughout the entire development process. We have therefore tried to optimise all parts that influence the biosecurity of our system as much as possible. To ensure maximum biosecurity, we have created and tested many designs, as well as extensively researched alternatives and/or additional elements that contribute to biosecurity. The biosafety of our Prime Editing complex has been a top priority throughout the entire development process. We have therefore tried to optimise all parts that influence the biosecurity of our system as much as possible. To ensure maximum biosecurity, we have created and tested many designs, as well as extensively researched alternatives and/or additional elements that contribute to biosecurity.
</p> </p>
...@@ -161,11 +161,11 @@ export const Safety: React.FC = () =>{ ...@@ -161,11 +161,11 @@ export const Safety: React.FC = () =>{
<Subesction title="Safety aspects of our Airbuddy" id="Biosafety2"> <Subesction title="Safety aspects of our Airbuddy" id="Biosafety2">
<H4 text="SORT LNP and Cytotoxicity"></H4> <H4 text="SORT LNP and Cytotoxicity"></H4>
<p> <p>
We have carefully considered the biosafety aspects of our delivery system, starting with the decision between Adeno-associated viruses (AAV) or LNPs as delivery systems. Our comparison revealed that the biocompatibility and safety of LNPs are paramount for our approach. That is why we chose selective organ-targeting (SORT) lipid nanoparticles (LNPs) [1] in the context of targeted pulmonary mRNA delivery. One of our primary concerns with the LNP was the potential cytotoxicity of polyethylene glycol (PEG), a common stabilizing agent in LNP formulations. Aware of the immune responses PEG can trigger, potentially leading to cytotoxicity [2], we aimed at optimizing its concentration in our SORT LNPs to minimize such reactions while maintaining therapeutic efficacy. By the use of low molecular weight PEG, we addressed this problem. To test weather our approach succeeded, we conducted MTT and proliferation assays to ensure that our LNP posed no cytotoxicity risks. We have carefully considered the biosafety aspects of our delivery system, starting with the decision between Adeno-associated viruses (AAV) or LNPs as delivery systems. Our comparison revealed that the biocompatibility and safety of LNPs are paramount for our approach. That is why we chose selective organ-targeting (SORT) lipid nanoparticles (LNPs) [7] in the context of targeted pulmonary mRNA delivery. One of our primary concerns with the LNP was the potential cytotoxicity of polyethylene glycol (PEG), a common stabilizing agent in LNP formulations. Aware of the immune responses PEG can trigger, potentially leading to cytotoxicity [8], we aimed at optimizing its concentration in our SORT LNPs to minimize such reactions while maintaining therapeutic efficacy. By the use of low molecular weight PEG, we addressed this problem. To test weather our approach succeeded, we conducted MTT and proliferation assays to ensure that our LNP posed no cytotoxicity risks.
</p> </p>
<H4 text="Precision of our SORT LNP"></H4> <H4 text="Precision of our SORT LNP"></H4>
<p> <p>
To further improve safety, we focused on reducing off-target effects. By incorporating specific SORT molecules, such as permanently cationic lipids like DOTAP, we ensured that the nanoparticles are systematically directed to the lungs. This precise targeting is particularly beneficial for respiratory diseases, as it enhances therapeutic effectiveness while limiting the impact on non-target organs. Our outlook of antibody conjugation as surface modification of our LNP for cell type-specific delivery, more exactly club cells [3] and ionocytes [4] as CFTR-expressing lung epithelial cells, would round off this aspect. To further improve safety, we focused on reducing off-target effects. By incorporating specific SORT molecules, such as permanently cationic lipids like DOTAP, we ensured that the nanoparticles are systematically directed to the lungs. This precise targeting is particularly beneficial for respiratory diseases, as it enhances therapeutic effectiveness while limiting the impact on non-target organs. Our outlook of antibody conjugation as surface modification of our LNP for cell type-specific delivery, more exactly club cells [9] and ionocytes [10] as CFTR-expressing lung epithelial cells, would round off this aspect.
</p> </p>
<p> <p>
In summary, our design strategy emphasizes both safety and efficacy. The careful optimization of components like PEG 2000 and the use of targeted delivery molecules allow SORT LNPs to deliver therapeutic agents directly to the lungs, reducing systemic exposure and minimizing side effects. This targeted approach ensures more effective treatments, especially for conditions requiring localized intervention. In summary, our design strategy emphasizes both safety and efficacy. The careful optimization of components like PEG 2000 and the use of targeted delivery molecules allow SORT LNPs to deliver therapeutic agents directly to the lungs, reducing systemic exposure and minimizing side effects. This targeted approach ensures more effective treatments, especially for conditions requiring localized intervention.
...@@ -187,24 +187,24 @@ export const Safety: React.FC = () =>{ ...@@ -187,24 +187,24 @@ export const Safety: React.FC = () =>{
We have investigated safety mechanisms to control the prime-editing complex, including a riboswitch that responds to sodium ion concentrations, but have discarded it due to suspected insufficient sensitivity. We are currently investigating the use of the ER stress response to activate the prime editing complex only in cells with high ER stress, as is typical for cystic fibrosis. Further details can be found in the Biosafety section. We have investigated safety mechanisms to control the prime-editing complex, including a riboswitch that responds to sodium ion concentrations, but have discarded it due to suspected insufficient sensitivity. We are currently investigating the use of the ER stress response to activate the prime editing complex only in cells with high ER stress, as is typical for cystic fibrosis. Further details can be found in the Biosafety section.
</p> </p>
</Subesction> </Subesction>
<Subesction title="Assesing Project Risks" id="Biosecurity2"> <Subesction title="Assessing Project Risks" id="Biosecurity2">
<p> <p>
Given the sensitive nature of genome editing, our project presents specific biosecurity concerns that need to be assessed and mitigated. Given the sensitive nature of genome editing, our project presents specific biosecurity concerns that need to be assessed and mitigated.
</p> </p>
<p> <p>
<strong>Dual-Use Potential:</strong> One of the main biosecurity risks is the potential for dual-use of the Prime Editing technology. The system we are developing, while intended for therapeutic use, could be misused to target other genes or genomes for malicious purposes.1 This includes the possibility of weaponizing the technology to induce harmful genetic changes in crops, animals, or even humans. The modular design of our plasmid system, although intended to facilitate optimization, could be exploited to exchange components for harmful applications, thereby increasing the risk of misuse. <strong>Dual-Use Potential:</strong> One of the main biosecurity risks is the potential for dual-use of the Prime Editing technology. The system we are developing, while intended for therapeutic use, could be misused to target other genes or genomes for malicious purposes.[11] This includes the possibility of weaponizing the technology to induce harmful genetic changes in crops, animals, or even humans. The modular design of our plasmid system, although intended to facilitate optimization, could be exploited to exchange components for harmful applications, thereby increasing the risk of misuse.
</p> </p>
<p> <p>
<strong>Unintendend Dissemination:</strong> Since our approach uses mRNA delivered via LNPs, there is a risk of unintended dissemination into the environment. If the LNPs are not adequately contained or disposed of, there is a possibility that they could be absorbed by non-target organisms, potentially leading to off-target genetic modifications.2 In addition, the mRNA itself could theoretically be transferred between cells, especially if taken up by unintended hosts, raising concerns about unintentional spread in the environment. <strong>Unintendend Dissemination:</strong> Since our approach uses mRNA delivered via LNPs, there is a risk of unintended dissemination into the environment. If the LNPs are not adequately contained or disposed of, there is a possibility that they could be absorbed by non-target organisms, potentially leading to off-target genetic modifications.[12] In addition, the mRNA itself could theoretically be transferred between cells, especially if taken up by unintended hosts, raising concerns about unintentional spread in the environment.
</p> </p>
<p> <p>
<strong>Unauthorized Access:</strong> The genetic constructs and the detailed methodology of our Prime Editing system must be securely stored and protected.3 If unauthorized individuals were to gain access to the plasmids, LNP formulations, or editing protocols, there is a risk of the technology being replicated or adapted for unintended, potentially harmful uses. This highlights the importance of proper biosecurity protocols in both physical and digital storage of our project materials. <strong>Unauthorized Access:</strong> The genetic constructs and the detailed methodology of our Prime Editing system must be securely stored and protected.[13] If unauthorized individuals were to gain access to the plasmids, LNP formulations, or editing protocols, there is a risk of the technology being replicated or adapted for unintended, potentially harmful uses. This highlights the importance of proper biosecurity protocols in both physical and digital storage of our project materials.
</p> </p>
<p> <p>
<strong>Synthetic Biology and information Sharing:</strong> The ease of synthesizing genetic material means that our project information could potentially be used to order similar constructs from commercial synthesis providers.4 While these providers follow biosecurity guidelines, the increasing accessibility of synthetic biology raises the concern of our Prime Editing system being reproduced or modified without our knowledge. This includes potential attempts to bypass safety mechanisms or create variants that evade current regulatory frameworks. <strong>Synthetic Biology and information Sharing:</strong> The ease of synthesizing genetic material means that our project information could potentially be used to order similar constructs from commercial synthesis providers.[14] While these providers follow biosecurity guidelines, the increasing accessibility of synthetic biology raises the concern of our Prime Editing system being reproduced or modified without our knowledge. This includes potential attempts to bypass safety mechanisms or create variants that evade current regulatory frameworks.
</p> </p>
<p> <p>
<strong>Public Perception and Miscommunication:</strong> There is a biosecurity risk in how our project's technology is communicated to the public.5 Miscommunication or misunderstanding of the project’s intent and capabilities could lead to misinformation, fear, or even attempts to replicate the technology outside of controlled and regulated environments. This could undermine public trust in legitimate therapeutic uses of genome-editing technologies and potentially facilitate misuse. <strong>Public Perception and Miscommunication:</strong> There is a biosecurity risk in how our project's technology is communicated to the public.[15] Miscommunication or misunderstanding of the project’s intent and capabilities could lead to misinformation, fear, or even attempts to replicate the technology outside of controlled and regulated environments. This could undermine public trust in legitimate therapeutic uses of genome-editing technologies and potentially facilitate misuse.
</p> </p>
</Subesction> </Subesction>
<Subesction title="Managing Risks" id="Biosecurity3"> <Subesction title="Managing Risks" id="Biosecurity3">
...@@ -277,13 +277,13 @@ export const Safety: React.FC = () =>{ ...@@ -277,13 +277,13 @@ export const Safety: React.FC = () =>{
<Section title="Bioethics" id="Bioethics"> <Section title="Bioethics" id="Bioethics">
<div> <div>
<p> <p>
Bioethics is an interdisciplinary field of research that addresses ethical issues pertaining to the life sciences and medical research. It plays a pivotal role in contemporary research, particularly in projects that employ human samples or data. This is due to the fact that in these cases, the protection of the rights and dignity of the people involved is of the utmost importance <SupScrollLink label="1"/> (Chadwick_2012_Thiele_2001a). In order to ascertain the necessity for an ethics application, an interview was conducted with Eva-Maria Berens, the scientific director of the office of the Ethics Committee at Bielefeld University, as part of the current research project. Following a comprehensive review, it was concluded that an ethics application was not necessary for the specific research project. Nevertheless, a comprehensive patient consent form was developed in conjunction with Eva-Maria Berens to guarantee that the donors of their samples are adequately informed and provide their consent of their own volition. The document guarantees that all pertinent information regarding sample collection, utilisation and storage is provided in an intelligible format. Furthermore, an interview was conducted with Dr. Timm Weber, a representative of the biobank, to discuss the topic of bioethics in greater depth. During the course of the interviews, the ethical aspects of sample storage and utilisation within the biobank were discussed in detail. Particular attention was paid to the responsible handling and protection of the rights of the test subjects. The discussion of bioethics in both interviews emphasises the relevance of ethical principles for research and ensures that it is conducted in accordance with the highest ethical standards. Bioethics is an interdisciplinary field of research that addresses ethical issues pertaining to the life sciences and medical research. It plays a pivotal role in contemporary research, particularly in projects that employ human samples or data. This is due to the fact that in these cases, the protection of the rights and dignity of the people involved is of the utmost importance <SupScrollLink label="1"/> [16]. In order to ascertain the necessity for an ethics application, an interview was conducted with Eva-Maria Berens, the scientific director of the office of the Ethics Committee at Bielefeld University, as part of the current research project. Following a comprehensive review, it was concluded that an ethics application was not necessary for the specific research project. Nevertheless, a comprehensive patient consent form was developed in conjunction with Eva-Maria Berens to guarantee that the donors of their samples are adequately informed and provide their consent of their own volition. The document guarantees that all pertinent information regarding sample collection, utilisation and storage is provided in an intelligible format. Furthermore, an interview was conducted with Dr. Timm Weber, a representative of the biobank, to discuss the topic of bioethics in greater depth. During the course of the interviews, the ethical aspects of sample storage and utilisation within the biobank were discussed in detail. Particular attention was paid to the responsible handling and protection of the rights of the test subjects. The discussion of bioethics in both interviews emphasises the relevance of ethical principles for research and ensures that it is conducted in accordance with the highest ethical standards.
</p> </p>
</div> </div>
<Subesction title="Gene Therapy" id="Bioethics1"> <Subesction title="Gene Therapy" id="Bioethics1">
<div> <div>
<p> <p>
The potential of gene therapy to treat genetic diseases is promising, but it is also associated with significant ethical issues. One of the principal challenges is ensuring the safety of the procedure and the potential for unforeseen long-term consequences. Such consequences may only become apparent years after the genetic intervention has taken place. The modification of the germline, which affects not only the individual but also future generations, is a particularly sensitive issue. This gives rise to the question of the extent to which the decisions made today will influence future generations without their consent, thereby jeopardising intergenerational justice <SupScrollLink label="2"/> (Rubeis_Steger_2018). Another ethical issue is the potential for misuse for eugenic purposes. While the current focus is on combating disease, future applications could be aimed at 'optimising' human traits, which could result in a worsening of social inequalities. Access to gene therapy is also a significant issue. High costs could limit access to wealthy population groups, which would reinforce existing inequalities <SupScrollLink label="3"/> (Ansah_2022_Cornetta_Patel_Wanjiku_Busakhala_2018). The issue of informed consent is also a key aspect. Many patients do not have the necessary knowledge to fully understand the complex risks, which raises ethical questions about their decision-making capacity. Overall, the debate around gene therapy highlights that ethical considerations such as safety, justice and patient rights need to be considered alongside scientific progress <SupScrollLink label="4"/> (Pugh_2020). The potential of gene therapy to treat genetic diseases is promising, but it is also associated with significant ethical issues. One of the principal challenges is ensuring the safety of the procedure and the potential for unforeseen long-term consequences. Such consequences may only become apparent years after the genetic intervention has taken place. The modification of the germline, which affects not only the individual but also future generations, is a particularly sensitive issue. This gives rise to the question of the extent to which the decisions made today will influence future generations without their consent, thereby jeopardising intergenerational justice <SupScrollLink label="2"/> [17]. Another ethical issue is the potential for misuse for eugenic purposes. While the current focus is on combating disease, future applications could be aimed at 'optimising' human traits, which could result in a worsening of social inequalities. Access to gene therapy is also a significant issue. High costs could limit access to wealthy population groups, which would reinforce existing inequalities <SupScrollLink label="3"/> [18]. The issue of informed consent is also a key aspect. Many patients do not have the necessary knowledge to fully understand the complex risks, which raises ethical questions about their decision-making capacity. Overall, the debate around gene therapy highlights that ethical considerations such as safety, justice and patient rights need to be considered alongside scientific progress <SupScrollLink label="4"/> [19].
</p> </p>
</div> </div>
</Subesction> </Subesction>
...@@ -291,11 +291,11 @@ export const Safety: React.FC = () =>{ ...@@ -291,11 +291,11 @@ export const Safety: React.FC = () =>{
<div> <div>
<H4 text="Introduction of primary cultures"></H4> <H4 text="Introduction of primary cultures"></H4>
<p> <p>
A primary culture is defined as a cell culture that is isolated directly from the tissue of an organism. In our case, the organism is human. The cells are then cultivated in a controlled environment, namely an S2 laboratory <SupScrollLink label="5"/> (Gstraunthaler_Lindl_2013). Primary cultures are a fundamental biomedical research tool, widely regarded as indispensable due to their capacity for realistic modelling of complex cell interactions. Primary cells are derived directly from the tissue of an organism and, as a consequence, they essentially retain their original properties. Consequently, they mirror the authentic conditions of the target tissue, which is vital for accurately assessing the impact of a therapeutic agent. In contrast, HEK cells represent transformed cell lines that exhibit physiological properties distinct from those of target cells in the human body. The effect of a therapeutic agent is typically limited to a specific cell type. The investigation of cell-specific effects and reactions of an active substance is feasible with the use of primary cells, as these possess the functional characteristics inherent to the cell type under consideration. Although HEK cells are relatively straightforward to cultivate, they are less representative of a number of tissue types and may activate other signalling pathways. The authenticity of the receptors and signalling pathways is guaranteed, as primary cells show the natural expression of receptors, ion channels and other cellular mechanisms. HEK cells are often genetically modified to express specific receptors, which can be useful for simple test systems. However, this does not reflect the complex environment of a real tissue. Given the sensitivity of primary cultures to environmental influences, thus resulting in higher risk of a contamination, it is imperative that researchers employ special safety measures to ensure the safety of themselves and the integrity of the cells. Primary cultures are employed extensively in the development of vaccines, cancer research and the investigation of basic cell processes. A primary culture is defined as a cell culture that is isolated directly from the tissue of an organism. In our case, the organism is human. The cells are then cultivated in a controlled environment, namely an S2 laboratory <SupScrollLink label="5"/> [20]. Primary cultures are a fundamental biomedical research tool, widely regarded as indispensable due to their capacity for realistic modelling of complex cell interactions. Primary cells are derived directly from the tissue of an organism and, as a consequence, they essentially retain their original properties. Consequently, they mirror the authentic conditions of the target tissue, which is vital for accurately assessing the impact of a therapeutic agent. In contrast, HEK cells represent transformed cell lines that exhibit physiological properties distinct from those of target cells in the human body. The effect of a therapeutic agent is typically limited to a specific cell type. The investigation of cell-specific effects and reactions of an active substance is feasible with the use of primary cells, as these possess the functional characteristics inherent to the cell type under consideration. Although HEK cells are relatively straightforward to cultivate, they are less representative of a number of tissue types and may activate other signalling pathways. The authenticity of the receptors and signalling pathways is guaranteed, as primary cells show the natural expression of receptors, ion channels and other cellular mechanisms. HEK cells are often genetically modified to express specific receptors, which can be useful for simple test systems. However, this does not reflect the complex environment of a real tissue. Given the sensitivity of primary cultures to environmental influences, thus resulting in higher risk of a contamination, it is imperative that researchers employ special safety measures to ensure the safety of themselves and the integrity of the cells. Primary cultures are employed extensively in the development of vaccines, cancer research and the investigation of basic cell processes.
</p> </p>
<H4 text="Ethics in work with primary cultures"></H4> <H4 text="Ethics in work with primary cultures"></H4>
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The term 'ethics' is used to describe the examination of moral principles that determine the behaviour of individuals or groups <SupScrollLink label="6"/> (Thiele_2001b). In a scientific context, the term 'ethics' encompasses the examination of the moral justifiability of actions and decisions, particularly with regard to the welfare of living beings and the responsible use of resources <SupScrollLink label="7"/> (Gethmann_2001). The isolation of primary cells from living organisms raises ethical questions, particularly in the case of human or animal tissue. In the context of research with animal primary cells, careful consideration must be given to the need for animal suffering and the potential benefits of the research <SupScrollLink label="8"/> (Kiani_Pheby_Henehan_Brown_Sieving_Sykora_Marks_Falsini_Capodicasa_Miertus_et al._2022). An ethical dilemma frequently arises from the fact that primary cells offer the most meaningful data from a biological standpoint, yet their production is associated with challenges. In this context, the necessity of primary cell cultures is called into question, and the promotion of alternative methods, such as artificially produced tissues or organoids, is advocated where feasible. It is of crucial importance to emphasize the necessity of ethical responsibility in the collection of primary cultures. It is of the utmost importance that the procedure is carried out with consideration for the rights, and particularly the well-being of the donor. The removal of cells or tissue must be medically justifiable and, moreover, ethically justifiable in every case. To this end, the potential for research use and the possible risks and burdens for the donor must be weighed against each other to ensure careful consideration. However, it is also particularly important to ensure that the donor is involved in the entire process and is able to make an informed decision. The purpose of the research, the use of the cells and possible consequences must also be made transparent at all times. The term 'ethics' is used to describe the examination of moral principles that determine the behaviour of individuals or groups <SupScrollLink label="6"/> [21]. In a scientific context, the term 'ethics' encompasses the examination of the moral justifiability of actions and decisions, particularly with regard to the welfare of living beings and the responsible use of resources <SupScrollLink label="7"/> [22]. The isolation of primary cells from living organisms raises ethical questions, particularly in the case of human or animal tissue. In the context of research with animal primary cells, careful consideration must be given to the need for animal suffering and the potential benefits of the research <SupScrollLink label="8"/> [23]. An ethical dilemma frequently arises from the fact that primary cells offer the most meaningful data from a biological standpoint, yet their production is associated with challenges. In this context, the necessity of primary cell cultures is called into question, and the promotion of alternative methods, such as artificially produced tissues or organoids, is advocated where feasible. It is of crucial importance to emphasize the necessity of ethical responsibility in the collection of primary cultures. It is of the utmost importance that the procedure is carried out with consideration for the rights, and particularly the well-being of the donor. The removal of cells or tissue must be medically justifiable and, moreover, ethically justifiable in every case. To this end, the potential for research use and the possible risks and burdens for the donor must be weighed against each other to ensure careful consideration. However, it is also particularly important to ensure that the donor is involved in the entire process and is able to make an informed decision. The purpose of the research, the use of the cells and possible consequences must also be made transparent at all times.
The obtaining of informed consent represents a fundamental aspect of ethical practice in the collection of primary cells. This process must encompass not only a formal consent procedure, but also the provision of comprehensive information to donors regarding the collection, utilisation and prospective future applications of the cells. The act of consent must be given freely and without undue influence, and donors must be fully aware of the consequences of their participation. Furthermore, donors must be granted the right to revoke their consent at any time without consequence. Prior to the collection of cells, a comprehensive discussion is held with the donor, during which all pertinent details are elucidated and any queries or concerns they may have, are addressed. This guarantees that the donor is adequately informed and is thus able to make an autonomous decision based on a comprehensive understanding of the procedure. The obtaining of informed consent represents a fundamental aspect of ethical practice in the collection of primary cells. This process must encompass not only a formal consent procedure, but also the provision of comprehensive information to donors regarding the collection, utilisation and prospective future applications of the cells. The act of consent must be given freely and without undue influence, and donors must be fully aware of the consequences of their participation. Furthermore, donors must be granted the right to revoke their consent at any time without consequence. Prior to the collection of cells, a comprehensive discussion is held with the donor, during which all pertinent details are elucidated and any queries or concerns they may have, are addressed. This guarantees that the donor is adequately informed and is thus able to make an autonomous decision based on a comprehensive understanding of the procedure.
The protection of privacy and confidentiality is of paramount importance when working with primary cultures. Given that primary cultures are predominantly human tissue, they contain genetic information and other personal data that is sensitive and deserving of protection. It is therefore of great importance that the data is anonymized and kept strictly confidential in order to protect the identity of the donor. The protection of privacy and confidentiality is of paramount importance when working with primary cultures. Given that primary cultures are predominantly human tissue, they contain genetic information and other personal data that is sensitive and deserving of protection. It is therefore of great importance that the data is anonymized and kept strictly confidential in order to protect the identity of the donor.
Every person who has access to the data or samples must be obliged to comply with confidentiality standards. It must be ensured that all legal requirements for data protection are met, including compliance with data protection laws such as the GDPR in the EU. Every person who has access to the data or samples must be obliged to comply with confidentiality standards. It must be ensured that all legal requirements for data protection are met, including compliance with data protection laws such as the GDPR in the EU.
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